Vésale Bioscience’s Post

Therapeutic drug monitoring and precision dosing is the future of medicine and DoseMe's work with field experts and SMEs is absolutely a huge win in PR! Great article in Pharmacy Times and more news here: https://lnkd.in/epwRQWcQ

Optimizing beta-lactam therapy with prolonged infusions and TDM is a prime example of how precision in practice can improve patient outcomes and safety. Combining model informed precision dosing with TDM can be a step towards safe use of cefepime and reducing cefepime induced neurotoxicity (CIN) #NationalAdverseDrugEvent (ADE)Day #PrecisionMedicine #TherapeuticDrugMonitoring #MIPD #fourthcause #patientsafety

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases. "With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. "Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings." "The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn's disease and ulcerative colitis, which affect nearly 1 in 100 Americans," said Michael Osso, President & CEO of the Crohn's & Colitis Foundation. "The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines." "This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis," said Steven Taylor, President & CEO of the Arthritis Foundation. "We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem." "Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis," said Leah Howard, J.D., President and CEO of the National Psoriasis Foundation. "We welcome the introduction of this additional formulation to expand the array of options available to our community." #Crohnsdisease #ulcerativecolitis #arthritis #psoriasis #adalimumab #biosimilar #Cyltezo #BoehringerIngelheim #LifeForward

📣 Latest Original Article Published Online 📢 📚 Successful implementation of interchange of biologic medications in chronic arthritis after information of costs to prescribers ✒ Authors: Fernando Perez Ruiz, Elena Garmendia-Sanchez, Javier Arostegui-Lavilla, Javier Duruelo-Echevarrieta, Joana Atxotegi-Saenz de Buruaga, Mayra Nathali Rivas-Zavaleta, Javier Casas-Arrate, Maria del Consuelo Modesto-Caballero, Amaya de Basagoiti-Gorordo ✅ The article aims to evaluate the impact of prescription, cost, and switching policy on the rate of switching from reference products to biosimilars. 💡 Keywords: #Biologics, #Biosimilars, #Interchangeability, #Switching, #Cost 🔗 Read the full article: https://lnkd.in/gpkN_szn 📑 PDF: https://lnkd.in/gbcDp9KE 🔎 This article belongs to our special issue “Biosimilars: State of the Art in the Treatment of Rheumatic Diseases”, guest-edited by Prof. valderilio azevedo. (https://lnkd.in/gy2BXe3i)

Updated from 2020: NGDI UBC Researchers have developed a novel oral amphotericin B formulation in the treatment of #leishmaniasis & systemic fungal infections that is cost-effective, safe, tropically stable, accessible and with positive human phase 1a (single dose) and phase 1b (multiple dose) safety results. https://lnkd.in/gnCzhdTD #nanomedicine #drugdelivery #fungal #parasitic

📢 Latest Original Article Published Online 📢 📚 Successful implementation of interchange of biologic medications in chronic arthritis after information of costs to prescribers ✒ Authors: Fernando Perez Ruiz, Elena Garmendia-Sanchez, Javier Arostegui-Lavilla, Javier Duruelo-Echevarrieta, Joana Atxotegi-Saenz de Buruaga, Mayra Nathali Rivas-Zavaleta, Javier Casas-Arrate, Maria del Consuelo Modesto-Caballero, Amaya de Basagoiti-Gorordo ✅ The article aims to evaluate the impact of prescription, cost, and switching policy on the rate of switching from reference products to biosimilars. 💡 Keywords: #Biologics, #Biosimilars, #Interchangeability, #Switching, #Cost 🔗 Read the full article: https://lnkd.in/gpkN_szn 📑 PDF: https://lnkd.in/gbcDp9KE 🔎 This article belongs to our special issue “Biosimilars: State of the Art in the Treatment of Rheumatic Diseases”, guest-edited by Prof. valderilio azevedo. (https://lnkd.in/gy2BXe3i)

Oriola Corporation RWE Team proudly presents the first scientific article for the year 2024: The topic of this publication is extremely actual, as the legislation about interchange of biological medicines in pharmacies will be gradually implemented starting early this year. We ran a survey among patients using biological medicines with biosimilars. Based on the results, we can conclude that despite the possibility for pharmacy substitution, the future cost savings rely on decisions made by doctors at the time of prescribing the biological medication. Guidance regarding biosimilars would improve patients’ willingness towards the change, but also help pharmacists and prescribing doctors in their meaningful role. Please, read more about our study via the link below! https://lnkd.in/drmjECGZ Acknowledgements to all respondents for participating the survey, Oriola Research Pharmacies, the Finnish Rheumatism Association, and the IBD and Other Intestinal Diseases Association as well as other collaborators!

RNAi the new Lipitor? Alnylam and Roche with more good news today for Zilebesiran, largely confirming prior data release around reductions in blood pressure achieved with 600mg doses (dosed twice a year!). I'm sure Roche sure is glad they grabbed ex-U.S. rights for the drug late last year. This continues RNAi's march to addressing broader and broader indications beyond rare diseases. Alnylam also originally developed Inclisiran (Leqvio - now in Novartis' hands) for (effectively) high cholesterol. That drug is also dosed twice a year. GalNAc has done wonders for RNAi delivery to liver targets but the field still needs new delivery modalities to meaningfully go after extra-hepatic targets. This is always the key hurdle to genetic-based medicines due to their complexity and need to be delivered intracellularly. Still, this is another win for RNAi as it continues to address broader and broader indications. While mRNA gets all the headlines, RNAi quietly continues its market impact. #genetherapy #drugdevelopment #biotech https://lnkd.in/g8EYv8Aw

Glasgow Declaration: Increasing Access to Drug Utilization Data The EuroDURG (European Drug Utilization Research Group) community initiated an action to increase access to drug utilization (DU) data. DU research intends to support health authorities in the development of evidence-informed pharmaceutical policy and practice guidelines, with the interest of the patients and communities in mind. DU data is often challenging to access for researchers, in particular in resource-restricted settings. You can endorse the declaration as an individual or in the name of an organization, click here: https://lnkd.in/d-jpK9ed #eurodurg #ispe #drugutilizationresearch #accesstodata #DUdata EuroDURG International Society for Pharmacoepidemiology